Product and Regulatory Update on MedMira’s COVID-19 Product Family
03 Março 2021 - 9:28AM
MedMira Inc. (MedMira) (TSXV: MIR) announces the expansion of its
product portfolio and outlines the company’s COVID-19 market and
regulatory plan.
MedMira has utilized its patented Rapid Vertical
Flow® (RVF®) technology and developed the company’s first rapid
antigen test, VYRA CoV-2 Antigen Test (VYRA CoV-2), designed to
detect SARS-CoV-2 virus in the swab samples. VYRA CoV-2 product
expands the existing COVID-19 product family and directly addresses
the wishes of our customers for an equally fast, reliable, and
easy-to-use testing solution. VYRA CoV-2 saliva-based swab test is
designed to be non-invasive and user-friendly, making this test
more suitable for the home settings. “The successful development of
this test opens up a new product line that has been a pioneering
step for MedMira,” said Hermes Chan, CEO of MedMira. “With this we
offer customers our COVID-19 product bundle that can accommodate
various testing needs. For example, the VYRA CoV-2 can used to
determine if the person is infected; REVEALCOVID-19™ PLUS [PLUS]
tells if anti-SARS-CoV-2 antibodies are present; and our
REVEALCOVID-19™ Nab-Y [Nab-Y] neutralizing test can potentially
identify if the individual is immune to the virus.”
With the FDA’s current focus on the development
of the POC and home tests, MedMira received the pre-EUA submission
number for its PLUS product to also include the POC claim. Once
authorized by the FDA for distribution in the US, MedMira expects
to maximize the sale potential in the current market environment.
In preparation for the home test application, MedMira is now
working on collecting additional performance data required by the
Agency.
MedMira will send the pre-EUA requests to seek
the FDA authorization for REVEALCOVID-19™ Nab-Y and VYRA CoV-2
products, including the information required to support the POC
claim. MedMira is working on the collaboration with the National
Microbiology Lab to fulfill the additional requirements of the
second Interim Order. In the meantime, MedMira’s REVEALCOVID-19™
Total Antibody Test is sold in the European Union and is highly
valued by our European customers.
About MedMiraMedMira is a
leading developer and manufacturer of Rapid Vertical Flow®
diagnostics. The Company’s tests provide hospitals, labs, clinics,
and individuals with instant disease diagnosis, such as HIV,
Syphilis, Hepatitis, and SARS-CoV-2, in just three easy steps. The
Company’s tests are sold globally under the Reveal®, Multiplo® and
Miriad® brands. Based on its patented Rapid Vertical Flow®
Technology, MedMira’s rapid HIV test is the only one in the world
to achieve regulatory approvals in Canada, the United States,
China, and the European Union. MedMira’s corporate offices and
manufacturing facilities are located in Halifax, Nova Scotia,
Canada. For more information visit medmira.com. Follow us on
Twitter and LinkedIn.
This news release contains forward‐looking
statements, which involve risk and uncertainties and reflect the
Company’s current expectations regarding future events, including
statements regarding possible regulatory approval, product launch,
future growth, and new business opportunities. Actual events could
materially differ from those projected herein and depend on a
number of factors including, but not limited to, changing market
conditions, successful and timely completion of clinical studies,
uncertainties related to the regulatory approval process,
establishment of corporate alliances and other risks detailed from
time to time in the company quarterly filings. Neither TSX Venture
Exchange nor its Regulation Services Provider (as that term is
defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release.
MedMira ContactsMarkus Meile,
CFOTel: 902-450-1588Email: ir@medmira.com
MedMira (TSXV:MIR)
Gráfico Histórico do Ativo
De Dez 2024 até Jan 2025
MedMira (TSXV:MIR)
Gráfico Histórico do Ativo
De Jan 2024 até Jan 2025
